Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN (DIA-RAMADAN)

Servier

Status: Completed

Conditions: Type 2 Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT04132934

DIM-05762-004

Details and patient eligibility

About

The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa

Enrollment: 1,200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activities
• Male or female type 2 diabetic patients aged >18 years
• Patients with controlled or suboptimal controlled type 2 diabetes
• Patients with experience in SMBG controlling using glucometer
• Patients who are willing to fast during Ramadan
• Patients already treated with Gliclazide MR 60mg

Exclusion criteria

• Insulin therapy requirement
• Severe liver or renal failure
• HbA1c ≥ 9%
• Contraindication to gliclazide according to SmPC
• Pregnancy or breast feeding
• Previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year